Double connector 11ID/15OD 20x
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Doppelkonnektor 11ID/15OD 20x EUDAMEDDouble connector 11ID/15OD 20x FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Model / Reference
- MP02655 EUDAMEDFDA UDI2080326K19K010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675414520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080326K19K010NR EUDAMED
- 510(k) Number
- K222822 FDA UDI
- FDA Product Code
- BZE FDA UDI
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5270 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Straight/elbow breathing circuit connector, single-use
Double connector 11ID/15OD 20x by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI cdb9a8ba-4ce1-4b07-b327-8c99eccfabcc 33 fields · synced Jun 18, 2026
- EUDAMED f732caed-cd5d-4f0c-be51-507ba2224bc5 61 fields · synced Jun 18, 2026